Leica Cryostats — Class II medical device recall Z-1729-2019
Terminated recall by Leica Microsystems, Inc., reported 2019-06-12, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. The current labelling does not include any specific warning about usage of flammable freezing sprays. Such fla
| Recall number | Z-1729-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Leica Microsystems, Inc., Buffalo Grove, IL, United States |
| Recall initiated | 2019-05-03 |
| Classified | 2019-06-04 |
| Reported by FDA | 2019-06-12 |
| Terminated | 2023-09-28 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
| Countries outside the US | CA, MX |
| Serial numbers | 1437, 1439, 1442, 1444, 1446, 1448, 1450, 4090, 4092, 4133, 4135, 4145, 4147, 4149, 4152, 4154, 4157, 4158, 4160, 4166, 4168, 4170, 4173, 4179, 4180 and 48 more |
Product
Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications, including in-vitro diagnostic (IVD) applications.
Reason for recall
The current labelling does not include any specific warning about usage of flammable freezing sprays. Such flammable freezing sprays can potentially ignite and can cause serious injuries.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1729-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.